Pain Control Differences Between Oxycodone and Ibuprofen in Children With Isolated Forearm Injuries
Primary Purpose
Forearm Injuries, Pain, Acute, Pediatric ALL
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Oxycodone
Ibuprofen
Sponsored by
About this trial
This is an interventional treatment trial for Forearm Injuries focused on measuring oxycodone, ibuprofen
Eligibility Criteria
Inclusion Criteria:
- 6 to 17 year old children presenting for care in the St. Louis Children's Hospital Emergency Department
- Suspected acute (within 24 hours) isolated forearm fracture at the time of initial Triage assessment
- American Society of Anesthesiologist physical status (ASA-PS) classification of I or II
- Child with parent or legal guardian.
Exclusion Criteria:
- Multiple injuries
- Known adverse reaction to either ibuprofen or oxycodone pts with abnormal bones or metabolic conditions that affect bones
- Administration of any opioid within 2 hours prior to presentation
- Non-English speaking
- Foster care, police custody, presenting without legal guardian
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Ibuprofen Group
Oxycodone Group
Arm Description
To compare analgesia from ibuprofen to oxycodone in the initial treatment of acute pain in suspected isolated forearm fractures in children.
To compare analgesia from ibuprofen to oxycodone in the initial treatment of acute pain in suspected isolated forearm fractures in children.
Outcomes
Primary Outcome Measures
Pain reduction
An appreciable decrease in pain scores (2 point reduction) from presentation to discharge
Secondary Outcome Measures
Full Information
NCT ID
NCT04523623
First Posted
August 19, 2020
Last Updated
August 19, 2020
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04523623
Brief Title
Pain Control Differences Between Oxycodone and Ibuprofen in Children With Isolated Forearm Injuries
Official Title
Oxycodone or Ibuprofen for Suspected Isolated Forearm Fractures in Pediatric Patients: A Randomized Noninferiority Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 2020 (Anticipated)
Primary Completion Date
February 2021 (Anticipated)
Study Completion Date
February 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
Children presenting to the Emergency Room with the chief complaint of forearm injury and/or pain will be randomized to receive oral Oxycodone or Ibuprofen to control pain.
Detailed Description
A randomized, blinded cohort study. Consented patients will be randomized to receive either ibuprofen or oxycodone after initial RN patient assessment in Emergency Department Triage determines a need for radiographs to evaluate for possible forearm fracture. Pain assessment scores will be determined at Triage and at 30-minute intervals throughout the patient's course until the patient is discharged home or additional analgesic medication is administered.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Forearm Injuries, Pain, Acute, Pediatric ALL
Keywords
oxycodone, ibuprofen
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ibuprofen Group
Arm Type
Experimental
Arm Description
To compare analgesia from ibuprofen to oxycodone in the initial treatment of acute pain in suspected isolated forearm fractures in children.
Arm Title
Oxycodone Group
Arm Type
Experimental
Arm Description
To compare analgesia from ibuprofen to oxycodone in the initial treatment of acute pain in suspected isolated forearm fractures in children.
Intervention Type
Drug
Intervention Name(s)
Oxycodone
Intervention Description
oxycodone 0.2mg/kg, max 10mg to be administered, randomized between that and Ibuprofen
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Intervention Description
ibuprofen 10mg/kg, max 800mg, randomized between that and Oxycodone
Primary Outcome Measure Information:
Title
Pain reduction
Description
An appreciable decrease in pain scores (2 point reduction) from presentation to discharge
Time Frame
180 minutes total
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
6 to 17 year old children presenting for care in the St. Louis Children's Hospital Emergency Department
Suspected acute (within 24 hours) isolated forearm fracture at the time of initial Triage assessment
American Society of Anesthesiologist physical status (ASA-PS) classification of I or II
Child with parent or legal guardian.
Exclusion Criteria:
Multiple injuries
Known adverse reaction to either ibuprofen or oxycodone pts with abnormal bones or metabolic conditions that affect bones
Administration of any opioid within 2 hours prior to presentation
Non-English speaking
Foster care, police custody, presenting without legal guardian
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John E Graham
Phone
314-273-2734
Email
grahamje@wustl.edu
12. IPD Sharing Statement
Citations:
Citation
Ibuprofen or oxycodone? An observational cohort study of post emergency department discharge management of children's fracture pain. Ali S., Drendel A.L., Rosychuk R.J., Le May S., McGrath P., Carleton B., Johnson D.W. Canadian Journal of Emergency Medicine 2016 18 Supplement 1 (S47).
Results Reference
background
PubMed Identifier
18772726
Citation
Charney RL, Yan Y, Schootman M, Kennedy RM, Luhmann JD. Oxycodone versus codeine for triage pain in children with suspected forearm fracture: a randomized controlled trial. Pediatr Emerg Care. 2008 Sep;24(9):595-600. doi: 10.1097/PEC.0b013e3181850ca3.
Results Reference
background
PubMed Identifier
25358276
Citation
Kircher J, Drendel AL, Newton AS, Dulai S, Vandermeer B, Ali S. Pediatric musculoskeletal pain in the emergency department: a medical record review of practice variation. CJEM. 2014 Nov;16(6):449-57. doi: 10.1017/s1481803500003468.
Results Reference
background
PubMed Identifier
29114833
Citation
Chang AK, Bijur PE, Esses D, Barnaby DP, Baer J. Effect of a Single Dose of Oral Opioid and Nonopioid Analgesics on Acute Extremity Pain in the Emergency Department: A Randomized Clinical Trial. JAMA. 2017 Nov 7;318(17):1661-1667. doi: 10.1001/jama.2017.16190.
Results Reference
background
PubMed Identifier
30810754
Citation
Ilyas AM, Miller AJ, Graham JG, Matzon JL. A Prospective, Randomized, Double-Blinded Trial Comparing Acetaminophen, Ibuprofen, and Oxycodone for Pain Management After Hand Surgery. Orthopedics. 2019 Mar 1;42(2):110-115. doi: 10.3928/01477447-20190221-02. Epub 2019 Feb 27.
Results Reference
background
PubMed Identifier
25624387
Citation
Kelly LE, Sommer DD, Ramakrishna J, Hoffbauer S, Arbab-Tafti S, Reid D, Maclean J, Koren G. Morphine or Ibuprofen for post-tonsillectomy analgesia: a randomized trial. Pediatrics. 2015 Feb;135(2):307-13. doi: 10.1542/peds.2014-1906.
Results Reference
background
PubMed Identifier
24904812
Citation
Moradi M, Esmaeili S, Shoar S, Safari S. Use of oxycodone in pain management. Anesth Pain Med. 2012 Spring;1(4):262-4. doi: 10.5812/aapm.4529. Epub 2012 Apr 1.
Results Reference
background
PubMed Identifier
29107409
Citation
Tsze DS, von Baeyer CL, Pahalyants V, Dayan PS. Validity and Reliability of the Verbal Numerical Rating Scale for Children Aged 4 to 17 Years With Acute Pain. Ann Emerg Med. 2018 Jun;71(6):691-702.e3. doi: 10.1016/j.annemergmed.2017.09.009. Epub 2017 Nov 6.
Results Reference
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Pain Control Differences Between Oxycodone and Ibuprofen in Children With Isolated Forearm Injuries
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